Catalog Number 89-8507-400-10 |
Device Problems
Mechanical Problem (1384); Appropriate Term/Code Not Available (3191)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/31/2020 |
Event Type
Injury
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Manufacturer Narrative
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Zimmer biomet complaint (b)(4).The device was not returned to the manufacturer at the date of this report.A follow-up medwatch will be submitted once the investigation is completed or if any additional information is received.
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Event Description
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It was reported that the universal modular electric/battery single trigger handpiece, part number 89-8507-400-10, serial number (b)(4), was jamming and then got stopped while reaming during a hip replacement.A delay of 30 to 45 minutes in the surgery procedure was reported.The reason for the delay is unknown.There was no additional harm or injury to patient/operator reported.
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Event Description
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It was reported that the universal modular electric/battery single trigger handpiece, part number 89-8507-400-10, serial number (b)(6), was jamming and then got stopped while reaming during a hip replacement.A delay of 30 to 45 minutes in the surgery procedure was reported.The reason for the delay is unknown.There was no additional harm or injury to patient/operator reported.
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Manufacturer Narrative
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Zimmer biomet complaint (b)(4).Universal modular electric/battery single trigger handpiece, part number 89-8507-400-10, serial number (b)(6) was not returned for complaint investigation.Therefore, the device could not be visually inspected in an effort to confirm the defect.Design history record review was performed and no issue was discovered during the manufacturing process that could explain the defect reported.A follow-up medwatch will be submitted if the product is returned or if additional information is received.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.The motor was seized.Additionally, there was a leakage issue at the battery support.The motor, screws, and seals were replaced and resolved the reported issue.The potted wired controller, battery support, and seals were updated.Dhr review was performed.Device was 70 months old and is not out of box failure.Device is used for treatment.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Event Description
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No further event information available at the time of this report.
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Search Alerts/Recalls
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